View Clinical Trial (Medical Research Study)
Counseling for Primary Care Office-Based Buprenorphine
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06519 |
| Conditions: |
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Opiate Dependence |
| Purpose: |
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The major goal is to determine whether adding cognitive behavioral therapy to physician
management will increase the efficacy of buprenorphine/naloxone treatment in an office-based
primary care setting.
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| Study Summary: |
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To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing
buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician
Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy
(CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous
population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent
with federal regulations, is designed to reflect usual care by primary care physicians and
includes referral to ancillary services. CBT will be provided by skilled psychologists in
weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and
increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that
the addition of CBT to PM will lead to decreased illicit drug use, durable effects after
counseling has been discontinued, improved buprenorphine/naloxone adherence and will
demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone
maintenance in primary care. Primary outcome measures include reductions in illicit opioid
use and abstinence achievement, as assessed by weekly urine toxicology testing and self
report. Secondary outcome measures include retention in treatment, reductions in cocaine use
and HIV risk, decreased criminal activity and improved health and employment status.
Utilization and costs of services, spillover effects in the PCC, and patient and staff
perceptions of benefits and problems associated with primary care agonist maintenance
treatment will also be evaluated. The results of this study will help define the role of
professional evidence-based drug counseling in expanding access to treatment with
buprenorphine/naloxone
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| Criteria: |
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Inclusion Criteria:
- opioid dependence
Exclusion Criteria:
- current dependence on alcohol, cocaine, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or untreated major depression
- inability to read or understand English
- life-threatening or unstable medical problems
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| NCT ID: |
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NCT00632151 |
| Primary Contact: |
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Principal Investigator
David A. Fiellin, MD
Yale University
Christopher Cutter, PhD
Phone: 203-781-4650 ext. 277
Email: christopher.cutter@yale.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Haven, Connecticut 06519
United States
Christopher Cutter, Ph.D.
Phone: 203-781-4650
Email: christopher.cutter@yale.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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